ICH E3 STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS
Title:
ICH E3 STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS
Origin/Publisher:
ICH
Content:
This document describes the format and content of a study report that will be acceptable in all three ICH regions. It consists of a core report suitable for all submissions and appendices that need to be available but will not be submitted in all cases.